DARZALEX - Storage and Stability of Vials at Freezing Temperatures

SUMMARY  

• Please refer to local prescribing information for storage and stability information.
• Johnson & Johnson cannot recommend any practices, procedures, or storage conditions that deviate from product labeling and are not approved by the regulatory agencies.

STABILITY AND TEMPERATURE EXCURSION DATA

• DARZALEX (100 mg/5 mL and 400 mg/20 mL) vials without sorbitol¹:
  • Stability studies support a 24-month expiration-dating period for DARZALEX vials when stored at 2°C to 8°C (36°F to 46°F) and protected from light, with excursions permitted between -20°C to -1ºC (-4°F to 30.2°F) for up to 6 days cumulative exposure with a maximum of 3 excursions.
• DARZALEX (100 mg/5 mL and 400 mg/20 mL) vials containing sorbitol²:
  • Stability studies support a 24-month expiration-dating period for DARZALEX vials when stored at 2°C to 8°C (36°F to 46°F) and protected from light, with excursions permitted between -20°C to 1ºC (-4°F to 33.8°F) for up to 9 days cumulative excursions in no more than 3 excursions (3 days each).
• This data was collected in a strictly controlled environment. The response above provides information on a specific scenario for which we have data. If there is no tracking of time and temperature, Janssen cannot provide recommendations.

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 12 August 2026.